Epilepsy Cycles Longitudinal Monitoring to Inform Personalized Seizure-risk Estimation (ECLIPSE)
United States14 participantsStarted 2025-05-01
Plain-language summary
The occurrence of seizures in epilepsy is not entirely random. Temporal patterns that organize the occurrence of seizures over weeks and months were previously unraveled using intracranial EEG System (IEEG) that monitors epileptic brain activity chronically. Seizures typically recur with patient-specific periodicity and are preceded by increases of epileptic brain activity over days. Here, the investigators developed new methods to forecast seizure likelihoods at a 24-h horizon. In this trial, participants will be provided with daily estimates about their upcoming risk of seizures. As a primary outcome, the performance of forecasts will be evaluated against the occurrence of electrographic seizures. As secondary outcome, the forecast's potential benefit for users in conveying actionable information in real-life will be assessed.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult with diagnosed pharmacoresistant epilepsy and at least one self-reported seizure in the last 12 months.
* Patients previously implanted with the RNS System, on stable detection settings enabling reliable detection of electrographic seizures.
* Patients willing and able to keep a diary, issue self-forecasts, and follow instructions.
* Home equipped with an internet connection.
* Informed Consent signed by the subject
Exclusion Criteria:
* Insufficient number of electrographic seizures or insufficient forecasting performance in the training phase.
* Women pregnant at the time of recruitment (later pregnancy not a contra-indication)
* Subjects with a history of psychogenic non-epileptic seizures
* Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
* Vulnerable subjects, including severe cognitive impairment precluding informed consent
* Drug or alcohol addiction
* Subjects who are unable (i.e., mentally or physically impaired patients) or do not have the necessary assistance, to properly operate the device system.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Forecast performance
Timeframe: At least on the first 10 seizures since enrollment. Expected within 6-12 months from enrollment.